Transcript Practice Basics - American Society of Health System

Chapter 15: Nonsterile Compounding and
Repackaging
Learning Outcomes
 Define compounding.
 Describe steps involved in compounding process
 Describe equipment commonly used for compounding
 Identify types of preparations commonly compounded
 Explain reasons for repackaging medications
 Explain importance of record keeping for
compounding & repackaging
Key Terms
 Active ingredient
 Batch record (or batch log)
 Batch repackaging
 Beyond-use
 Blister packages
 Compounding
 Compounding environment
 Compounding record
Key Terms
 Extemporaneous repackaging
 Formulation record
 Geometric dilution
 Graduates
 Inactive ingredient
 Levigation.
 Manufacturing
 Nonsterile compounding
Key Terms
 Peristaltic pumps
 Prescription compounding
 Stability
 Sterile compounding
 Trituration
 Unit-dose package
 Unit-of-use packaging
 Volumetric pumps
Prescription Compounding
 Meets unique needs of patient
 Medication strength/dose not commercially available
 Compounding associated with specialty practice areas
 veterinary medicine
 dermatology
 hormone replacement therapy
 pain management
 hospice
 home care
Compound or Manufacture?
 Compounding: prepare small quantity of drug
 based on practitioner’s prescription
 for specific patient
 Manufacturing: prepare bulk quantities
 without prescription or medication order
Types of Compounding
 Sterile compounding
 strict aseptic technique
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

injections
ophthalmic solutions
irrigation solutions
 Nonsterile compounding
 oral & topical medications
USP-NF Chapter 795
 United States Pharmacopeia-The National Formulary
 Guidelines & an enforceable set of standards
 Describes procedures/requirements for compounding
 Intent of USP is to protect both patients & pharmacists
Compounding Environment
 Adequate space
 orderly placement & storage of equipment
 Controlled temperature/lighting
 Clean
 Sink with hot & cold running water
 essential for hand washing & equipment cleaning
Compounding Equipment
 Equipment must be:
 appropriate in design & size for intended purpose
 must always be cleaned immediately after use
 must be properly maintained & calibrated
 Must have separate & distinct areas for compounding
sterile & nonsterile preparations
Stability of Preparations
 Primary packaging important
 Examples

light sensitive drugs or drugs that bind to container
 Beyond-use date (BUD) on label of all medications
 Determining beyond-use dates based on
 aqueous (water-based) or nonaqueous
 expiration dates of ingredients used
 storage temperature
 references with stability data
Ingredient Selection
 USP or National Formulary (NF) chemicals preferred
 Pharmacist responsible for selection
 chemical must meet meets purity & safety standards
 should not use drug withdrawn from market by FDA
Compounded Preparations
 Guideline:
 should contain between 90% & 110% of labeled active
ingredient
 Guidelines specifically address these dosage forms:
 capsules, powders, lozenges, tablets, emulsions,
solutions, suspensions, suppositories, creams, topical
gels, ointments, pastes
Compounding Process
 Goal of compounding process
 “minimize error and maximize prescriber’s intent”
 Pharmacist evaluates appropriateness of order
 Only 1 preparation should be compounded at a time
 avoid errors
 avoid cross-contamination
Steps in Compounding
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Calculate amount of ingredients for preparation
Identify equipment needed
Wash hands & wear proper attire
Clean compounding area & needed equipment
Collect all materials & ingredients
Compound prep following formulation record
Document name on compounding record/log
Label final preparation appropriately
Properly clean & store all equipment
Final Check
 Pharmacist is responsible for checking final prep
 weight variation
 proper mixing
 odor
 color
 consistency
 pH if appropriate
 Pharmacist signs & dates prescription
 documenting/ensuring quality
Compounding Records
 USP Chapter 795 requires pharmacies to maintain
 formulation record (master formula)
 compounding record for each compounded preparation
 Formulation record-an individual record (like a recipe)
 filed alphabetically
 listing of the
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

ingredients
compounding equipment
instructions for preparing formula
Compounding Record
 Log of an actual compounded preparation
 based on an individual prescription
 batch may be prepared in anticipation of orders
 includes manufacturer & lot numbers of chemicals
 date of preparation
 internal identification number
 beyond-use date
 names of individuals who prepared & verified
Records
 Compounding record for batch (batch record)
 filed by lot number
 Compounding record for an individual prescription
 chronological list of preparations made
 Formulation & compounding records
 maintained as paper copies or electronically
Quality Control
 Final check on preparation
 Pharmacist must evaluate
 finished preparation
 compounding procedure
 Discrepancies should be noted & evaluated
 Patient Counseling
 important with all medications
 correct use, storage, beyond-use date, evidence of
instability in compounded medication
Inactive Ingredients
needed to prepare formulation
not intended to cause pharmacologic response
 Diluents or fillers
 Emulsifying agents or surfactants
 Binders
 Coating agents
 Colorants
 Preservatives
 Lubricants
 Perfumes
 Flavorants
 Acidifying agents
 Sweeteners
 Alkalizing agents
 Suspending agents
 Wetting agents
 Vehicles
Compounding Equipment
 Electronic or class A torsion balance
 Powder papers or weigh boats
 Brass weight sets with class A torsion balances
 Graduates
 Mortars & pestles
 Ointment slab (pill tile) & spatulas
 trituration
 levigation
 geometric dilution
 Electronic mortar & pestle
 Hot plates
 Refrigerator with freezer
 Stirring rods
 Stir plates with magnetic stir bars
 Strainers
 Molds for suppository, troche
 Blenders
 Capsule filling equipment
 Mixers
 Motorized stirrers
Compounded Preparations
 Commonly compounded preparations
 ointments
 creams
 solutions
 suspensions
 suppositories
 lozenges/troches
 capsules
Ointments & Creams
 Active ingredient in commercially prepared base
 petrolatum-based products
 emollient creams
 vanishing creams
 Choice of base depends on condition being treated
 Examples of medications in creams & ointments
 corticosteroids
 antifungals
 antibiotics
 hormones
Solutions & Suspensions
 One or more drug ingredients
 Mixed in homogenous or single phase
 No visible undissolved particles
 Solutions
 solid drug that dissolves in liquid
 Suspensions
 two phases:


insoluble solid particles (active ingredient)
liquid
Suspensions
 Insoluble particles settle to bottom
 Suspending agents
 added to allow insoluble particles to re-suspend
 Suspensions
 levigate insoluble powder to smooth paste
 appropriate wetting agent
 Flavoring & sweetening agents
Suppositories
 Suppositories may contain
 analgesics
 hormones
 anti-nausea agents
 laxatives
 vaginal anti-infectives
 Once inserted, suppository melts or dissolves
 suppositories must remain solid at room temperature &
melt at body temperature
Lozenges/Troches
 Also known as pastilles
 Small, medicated squares can be soft or hard
 Intended to dissolve slowly between cheek & gum
 Medication(s) absorbed through oral mucosa
 Useful for pediatric & geriatric patients
Capsules
 Capsule-filling machine
 Powders mixed in mortar, zippered plastic bag, or
specialized blender
 Lids or capsule tops are removed
 Capsules drop even with plate
 Powder is distributed into capsules
 Lids or tops are replaced
 Numerous capsule sizes & colors available
Other Compounds
 Powders are very fine, dry active & inactive ingredients
 Granules are powders moistened & passed through
screen
 Emulsions are mixture of 2 immiscible liquids
 Gels are semi-solid systems consisting of suspensions
 Tablets are made by compression
Repackaging
 Pharmacies repackage medications from bulk
containers into patient-specific containers
 unit-of-use
 single-unit
 unit-dose
Extemporaneous Versus Batch
 Extemporaneous repackaging
 quantities to be used within short period of time
 done on an “as needed” basis
 based on anticipated immediate need
 also known as “just-in-time” packaging
 Batch repackaging
 periodic repackaging of large quantities of medications
 unit-dose or single-unit packages
 extended stability
 prescribed more frequently
Packaging
 Prepare in advance = pre-packaging
 Saves
 time
 materials
 money
Repackaging Materials
 Must protect drug from
 harmful external elements
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light
heat
moisture
air
microbial contaminants
 USP defines containers & closures
 based on degree to which contents protected
Repackaging Equipment
 Oral Solid Systems
 blister packages
 pouch packages
 Manual Systems
 Automated Systems
 Oral Liquid Systems
 Semi-automated Systems
 Volumetric pumps
 Peristaltic pumps
Beyond-Use Dating & Labeling
 Labeling-responsibility of dispenser
 storage conditions
 beyond-use date
 USP offers standards for determining an appropriate
expiration date in absence of published stability data
USP Guidance:
 “For nonsterile solid and liquid dosage forms that are
packaged in single-unit and unit-dose containers, the
beyond use date shall be one year from the date
packaged or the expiration date on the manufacturer’s
container, whichever is earlier.”
ASHP Guidance
 Current federal labeling requirements
 Described in ASHP Technical Assistance Bulletin on
Single Unit and Unit Dose Packages of Drugs
 Generic name & brand name
 Dosage form, strength, amount delivered in package,
notes
 Expiration date
 Control number or lot number
 Bar code
Record Keeping
 Standards of practice & government regulations
 maintaining accurate, complete records
 focal point for quality assurance program
 maximize technician’s role in repackaging
 repackaging record systems
 computerized
 individual state laws & regulations will dictate:

what needs to be kept, whether records may be maintained as
paper or electronic records, how long records must be
maintained
Quality Control
 Ensures high-quality repackaged medications
 Quality control
 written procedures
 formal training for operators of equipment
 maintenance of equipment
 checkpoints during process
 end product testing
 strict adherence to good manufacturing practices (GMP)
GMP
 Refers to guidelines of production
 Manufacturing/repackaging processes clearly defined
 Instructions/procedures are written in clear language
 Documentation of personnel training
 Records: show procedures were followed
 Storage & distribution of final product minimizes
negative effects to quality
 System for recalling any batch of product
GMP
 Written Procedures
 Personnel Training and Competency
 Maintenance of Equipment
 End-Product Testing
Checkpoints May Include:
Double-checking drug & dosage
2. Double-checking fill volumes
3. Double-checking calculations
4. Double-checking information on label
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